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Brimonidine 0.1% Versus Brinzolamide 1% as Adjunctive Therapy to Latanoprost 0.005%

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ClinicalTrials.gov Identifier: NCT00440141
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : January 2, 2008
Sponsor:
Information provided by:
Allergan

Brief Summary:
Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005%

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : July 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops
latanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months
Other Names:
  • Xalatan®
  • Alphagan® P

Active Comparator: 2 Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops
latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily for 3 months
Other Names:
  • Xalatan®
  • Azopt®




Primary Outcome Measures :
  1. IOP [ Time Frame: Month 3 ]

Secondary Outcome Measures :
  1. Tolerability [ Time Frame: Month 3 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Glaucoma or ocular hypertension in both eyes
  • Currently being treated with latanoprost 0.005% QD
  • IOP greater than or equal to 18mm Hg on latanoprost 0.005%
  • Best-corrected VA of 20/200 or better in each eye
  • Visual field within 6 months of study entry

Exclusion Criteria:

  • Secondary glaucoma
  • Active intraocular inflammation or macular edema
  • Intraocular surgery or laser surgery within the past 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440141


Locations
United States, Georgia
Atlanta, Georgia, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Affairs Allergan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00440141     History of Changes
Other Study ID Numbers: MA-AP01
First Posted: February 26, 2007    Key Record Dates
Last Update Posted: January 2, 2008
Last Verified: December 2007

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Tetrahydrozoline
Latanoprost
Brimonidine Tartrate
Brinzolamide
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors